Clarity Diagnostics Covid-19 Visual Antigen Rapid Test

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Covid Tests

V1001_000057_CLA-COV19AG-VIS_KT

Learn about Clarity Diagnostics Covid-19 Visual Antigen Rapid Test

Features:

  • The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
  • Relative Specificity: >98.9%
  • This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset
  • For prescription use only
  • Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests
  • Fast and Easy - Positive results as fast as 5 minutes
  • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
  • Relative Sensitivity 87.5%
  • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories
  • The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care

Specifications:

Country of Origin Finland
Application Rapid Test Kit
Brand Clarity
HCPCS U0003
Test Type Antigen Detection
UNSPSC Code 41116205
Sample Type Nasopharyngeal Swab Sample
Number of Tests 25 Tests
Test Name Covid-19 Antigen
Time to Results 5 Minute Results
Manufacturer # CLA-COV19AG-VIS
Reading Type Visual Read
Test Method Lateral Flow Immunoassay
CLIA Classification CLIA Waived for Point of Care
Test Format Cassette Format
Manufacturer Clarity Diagnostics LLC

Shipping, Payment, & Returns

Shipping

bttn offers a variety of shipping options to best fit your orders. All orders over $199 include free shipping. For those under $199, a $3 fee will be added, while those under $99 will have a $6 fee added for shipping. Products weighing over 100lbs will be marked in our system as “freight collect” and someone from our team will reach out to you directly to confirm shipping costs. For more information on our shipping policy, please refer to our shipping policy page.

Payment Options

Payments are accepted via card, check, or PO.

If you are paying by check, please promptly send all checks to 424 2nd Ave W, Suite 700 Seattle, WA 98119.

If paying by PO follow the steps below:
1) Ensure that your Purchase Order correctly reflects the order placed on bttnusa.com
2) Download your organization's PO to your computer
3) Open your email application
4) Create a new email with the subject line "Bttn (Order #)" PO
5) Add accounting@bttnusa.com as the recipient
6) Attach your organization's PO
7) Press Send

Return Policy

30-day return policy.

You can request a return up to 30 days after receiving your item. To be eligible for a return, your item must be in the same condition that you received it, unworn or unused, with tags, and in its original packaging. You’ll also need the receipt or proof of purchase.

To start a return, you can contact us. If your return is accepted, we’ll send you a return shipping label, as well as instructions on how and where to send your package. Items sent back to us without first requesting a return will not be accepted.

Contact us for any return questions at support@bttnusa.com